Senior Analyst Quality Control

Company: Disability Solutions
Location: Raritan
Posted on: August 31, 2024

Job Description:

Janssen Supply Chain Quality Control, US Stability Operations is recruiting for a Senior Analyst Quality Control! This position will be located in Raritan, NJ.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.The Senior Analyst QC manages and executes day-to-day Quality Control sample management activities for the NJ Stability laboratory, ensuring GMP compliance and accuracy and timeliness of specified stability processes. The Senior Analyst QC carries out duties in compliance with all local, state, federal and international regulations and guidelines (including FDA, EPA, OSHA, DEA, etc.) as well as all company and site policies and procedures.The Senior Analyst QC is accountable to manage and assure quality & compliance for all activities and ensure all regulatory commitments are met, including compliance to stability pull windows. They will represent stability operations as an SME for issues that arise in the area of Sample Management.Key Responsibilities:

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• Responsible for the daily pulling (physically and electronically) of samples in the stability chambers. --- Provide samples to the stability laboratory making sure all samples are pulled within compliance.
• Responsible for handling controlled substances in compliance with all applicable DEA regulations from arrival to final disposal.
• Responsible for managing the accurate receipt and storage of incoming sample shipments to the site, as well as the accurate shipping of samples to various other labs/sites
• Ensure all annual stability commitments are verified & labeled upon receipt into the Stability Monitoring Program and all monthly pulls are performed on time to meet regulatory commitments
• Conducts inventory check of all samples and reference standards
• Coordinate the acquisition, transportation, receipt, and storage of stability samples and associated reference standards from a global network of manufacturing facilities
• Maintain stability chambers to ICH guidelines and is act as the first line notification for the Environmental Monitoring System. Diligently respond 24/7 to chamber excursions and advise team members on system status
• Document chamber maintenance, repairs and excursions in logbooks.
• Interact with the manufacturing and packaging sites to ensure awareness of current stability policies and commitments, and to procure the necessary batches for the program
• Update protocols, studies and samples as needed in LIMS database
• Initiate, write and review technical documents including investigations, SOP's, protocol, reports, CAPA's, etc. associated with the duties of this position
• Support Health Authority inspections as Sample Management SME\r\r

Keywords: Disability Solutions, New Brunswick , Senior Analyst Quality Control, Professions , Raritan, New Jersey